Label: CREST PRO-HEALTH ADVANCED W/EXTRA DEEP CLEAN- sodium fluoride rinse
- NDC Code(s): 37000-866-01, 37000-866-02, 37000-866-03
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
-
Directions
- Adults and children 6 years & older:
- Use twice a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
- Do not swallow the rinse.
- Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: consult a dentist or doctor.
- Adults and children 6 years & older:
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
ALCOHOL FREE
WITH FLUORIDECrest®
PRO-HEALTH™
ADVANCED
ANTICAVITY FLUORIDE MOUTHWASHSTRONGER TEETH*
FOR A HEALTHIER MOUTHWITH
EXTRA DEEP CLEAN**IMPORTANT:
Read directions
for proper use.- KILLS BAD BREATH GERMS
- HELPS PREVENT CAVITIES
- STRENGTHENS ENAMEL
- CLEANS TEETH & GUMS
- FRESHENS BREATH
500 mL
(16.9 FL OZ)
-
INGREDIENTS AND APPEARANCE
CREST PRO-HEALTH ADVANCED W/EXTRA DEEP CLEAN
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-866 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHOSPHORIC ACID (UNII: E4GA8884NN) METHYLPARABEN (UNII: A2I8C7HI9T) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-866-01 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2016 2 NDC:37000-866-02 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2016 3 NDC:37000-866-03 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 07/29/2016 Labeler - The Procter & Gamble Manufacturing Company (004238200)